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FDA 510(k)

Stonetome Stone Removal Device

K-Number: K191789 · 2019-07-25

ApplicantBoston Scientific Corporation
Decision Date2019-07-25
Product CodeLQR
Advisory CommitteeGU
DecisionUnknown

Device Summary

Stonetome Stone Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K191789. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Stonetome Stone Removal Device?

Stonetome Stone Removal Device is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Boston Scientific Corporation. The 510(k) number is K191789.

When did Stonetome Stone Removal Device receive FDA 510(k) clearance?

Stonetome Stone Removal Device received FDA 510(k) clearance on 2019-07-25, under 510(k) number K191789.

Who is the listed applicant for Stonetome Stone Removal Device?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stonetome Stone Removal Device?

The FDA product code for Stonetome Stone Removal Device is LQR.

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Related Devices (Code: LQR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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